Vascular and intestinal occlusion

ABSTRACT

A device for occluding a conduit includes first and second members, each with first and second ends. The second ends are connected by a hinge. The first ends interlock to close the device about the conduit. The members are shaped such that they can occlude the conduit without causing the development of damaged or necrotic tissue. If desired, a flexible cover can be provided and the first and second members can be disposed within the cover. If such a cover is used, it will contact the conduit in order to cushion the contact between the members and the conduit, minimize the tendency of the conduit to bleed, and increase traction relative to the conduit. The invention also includes methods for using the device to occlude a conduit.

REFERENCE TO RELATED APPLICATION

The present application is a continuation-in-part of application Ser.No. 11/315,799, filed Dec. 22, 2005 by Robert E. Michler and Albert N.Santilli, entitled Exclusion of the Left Atrial Appendage (“the LAApatent”), the disclosure of which is incorporated herein by reference.

BACKGROUND OF THE INVENTION

Field of the Invention

The invention relates to techniques for performing vascular andintestinal occlusion and, more particularly, to a clamp for suchocclusion.

Description of the Prior Art

The body contains many conduits that accommodate a flow of fluids orsemi-solids. Such conduits include the intestines and blood vessels,both veins and arteries. Many surgical procedures require that the flowin such conduits be reduced or halted (“occlusion”) while surgicalprocedures such as anastomosis are performed. For convenience, anyportion of the intestinal tract, any vascular member, or any otherportion of the body that transports or convey fluids, semi-solids, orother material will be referred to herein as a “conduit” or “conduits.”

Occlusion in conduits typically is accomplished by devices commonlyreferred to as clamps or clips. In general, these devices have opposingjaws that are adapted to extend over the conduit and to pinch the wallsof the conduit against themselves in order to inhibit or stop flowthrough the conduit. The jaws commonly associated with clamps arerelatively long and are operable by scissor-type handles which provideleverage for the jaws. Representative clamps of this type are shown inU.S. Pat. Nos. 5,019,092 and 5,447,515, the disclosures of which areincorporated herein by reference. Clamps commonly are used to occludelarger conduits such as the intestines. By comparison, the jaws of clipsare relatively small and are biased by a spring commonly used to occludesmaller conduits such as blood vessels. As used herein, the term “clamp”will refer not only to clips and clamps, but also to other types ofocclusion devices which have opposing jaws.

Conduits typically have a relatively smooth outer surface which often iswetted by body fluids such as blood. Attempts to occlude such conduitsby pinching their walls must meet several objectives. The primaryobjective is to accomplish the occlusion, but of no less importance is asecond objective, which is to maintain the clamp in place. Anotherobjective is to occlude the conduit without causing tissue damage ornecrosis, sometimes attributed to localized pressure or stressconcentrations.

Traction is related to the resistance of the clamp to movement relativeto the tissue. Theoretically, traction is equivalent to the product ofthe coefficient of friction, which is dependent upon the nature of thecontacting surfaces, and the normal or clamping force. In the past,attempts have been made to increase this clamping force in order toincrease the traction. Unfortunately, squeezing a conduit with a greaterforce tends to traumatize the tissue and in the case of blood vessels,destroy the intimal lining which cannot be regenerated. As a result, itis desirable to have only sufficient clamping force to achieve the firstobjective, that is, the occlusion of the conduit. Increasing theclamping force to achieve the second objective, that is, to increasetraction, generally is not a suitable alternative.

Attempts have been made to increase the coefficient of friction in orderto enhance the traction of the clamp relative to the conduit. This hasbeen complicated by the wetness of the tissue surface of the conduit.U.S. Pat. No. 3,746,002 discloses an atraumatic surgical clamp having aplurality of pin members which extend though a resilient pad and whichengage the tissue when the pad is compressed. Since the pins stick intothe tissue, this produces a highly traumatic effect in most cases. Lessaggressive attempts to increase the coefficient of friction have notalways been sufficient to maintain the clamp in place, even after theconduit has been occluded.

Resilient pads, commonly referred to as inserts, have been provided forattachment to the inner surfaces of the opposing jaws. These insertstypically have a tissue-contacting surface which faces the opposing jaw,as well as a pair of side-surfaces which extend laterally of the insert.The inserts have been formed of resilient foam, in some cases withirregular surfaces. Other inserts have included fibers in the nature oftoothbrush bristles to increase traction. Such inserts have experiencedproblems in either successfully occluding the conduit or in maintainingproper traction thereon. Examples of these various types of devices inquestion are shown in U.S. Pat. Nos. 4,106,508; 4,708,140; 4,98,355; and6,579,304, the disclosures of which are incorporated herein byreference.

Unfortunately, although existing externally applied devices andtechniques appear to offer a relatively simple and effective approach tothe problem of occluding a conduit, a significant problem that remainsis that of tissue damage, possibly even necrosis. If the compressiveforce that is applied to the conduit is too great, or if compression islocalized in some areas and not others, the device either could causeundesired cell destruction or it could fail to perform its occlusionfunction properly.

Desirably, an externally applied exclusion device for a conduit would beavailable that would be easy to apply and remove. Any such devicepreferably would apply the proper amount of compressive force to occludethe conduit while avoiding any stress concentrations that would lead toundesired tissue damage or necrosis. Moreover, any such device hopefullywould avoid punctures that would lead to difficult-to-control bleeding.Yet additionally, any such device would have adequate traction tomaintain the device in its proper position on the conduit.

SUMMARY OF THE INVENTION

In response to the foregoing concerns, the present invention provides anew and improved technique for occluding conduits. The invention employsa device similar to that disclosed in the LAA patent and uses thatdevice for occluding conduits. The device in question includes a firstmember having first and second ends adapted to extend from one side of aconduit to the other and to contact the conduit on a selected sidethereof and a second member having first and second ends adapted toextend from one side of the conduit to the other and to contact theconduit on the other side thereof. The first and second members in useare disposed generally parallel with each other and are disposedsufficiently close to each other to compress the conduit between themwithout causing the development of necrotic tissue. Those portions ofthe first and second members that contact the conduit are configured tominimize stress concentrations in the conduit.

Preferably, those portions of the first and second members that comeinto contact with the conduit are rounded. It also is possible for thefirst and second members, in cross-section, to be rectangular withrounded ends, the longer dimension of the rectangle adapted to contactthe conduit. The first and second members may be straight, or they canhave a non-straight configuration such as arc-shaped when viewed fromabove. In the preferred embodiment, a hinge connects the second ends ofthe first and second members, the hinge comprising an integral extensionof the second ends of the first and second members. The preferredembodiment also provides that the first ends of the first and secondmembers interlock with each other to maintain the first and secondmembers in a fixed position relative to each other.

It is possible to provide a flexible cover for the first and secondmembers. The cover can be made of a number of materials that arebiocompatible with the conduit and which provide suitable traction, buta flexible covering in the form of a mesh made of polyester fabric ispreferred. Such a flexible cover will tend to cushion the contactbetween the conduit and the device and will assist in preventingundesired bleeding and movement of the device relative to the conduit.

The invention also includes a method for occluding a conduit comprisingthe step of providing a first, elongate member having first and secondends, the first member having a cross-section that will minimize stressconcentrations in the conduit, the first member being long enough toextend from one side of the conduit to the other. The method alsoincludes the step of providing a second, elongate member having firstand second ends, the second member having a cross-section that willminimize stress concentrations in the conduit, the second member beinglong enough to extend from one side of the conduit to the other. Themethod provides for disposing the first and second members on eitherside of the conduit with the first and second members generally parallelwith each other and for moving the first and second members sufficientlyclose to each other to compress the conduit between the first and secondmembers without causing the development of necrotic tissue. The methodalso calls for maintaining the first and second members in a compressedposition relative to the conduit.

Further embodiments of the method according to the invention include thestep of providing a flexible container for the first and second members.The container is long enough to receive both the first and secondmembers. The container is made of a material that is biocompatible withthe conduit and that will increase the traction of the device on theconduit. The invention includes the step of placing the first and secondmembers in the container prior to the step of disposing the first andsecond members on either side of the conduit with the longitudinal axesof the first and second members generally parallel with each other. Ifdesired, and if the nature of the conduit permits, the method caninclude the step of suturing the flexible container to the conduit.

By using the present invention, a surgeon can quickly and easily occludea conduit during the course of various surgical procedures such asanastomosis. The device according to the invention applies the properamount of compressive force to occlude the conduit while avoiding stressconcentrations that would lead to undesired tissue damage or necrosis.Moreover, the device will avoid punctures that would lead todifficult-to-control bleeding. The foregoing and other features andadvantages of the invention will be apparent from a review of thefollowing description of the invention, taken together with the attacheddrawings,

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevation view of an occlusion device in accordancewith one embodiment of the present invention, the embodiment shown beingin an open position and having a flexible cover coupled thereto;

FIG. 2 is a view of the occlusion device of FIG. 1 with the coverremoved and the device in a closed position;

FIG. 3 is a perspective view of the device of FIG. 1 with the coverremoved and the device in an open position;

FIG. 4 illustrates the device of FIG. 1 as used on a conduit to occludethe conduit;

FIG. 5 is an enlarged sectional view taken along a plane indicated byline 5-5 in FIG. 4;

FIG. 6 shows the device of FIG. 5 in an open position;

FIG. 7 is a side elevation view of an occlusion device in accordancewith another embodiment of the present invention, the embodiment shownhaving arc-shaped first and second members; and

FIG. 8 is a top plan view of the device of FIG. 7 as used on a conduitto occlude the conduit.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to FIGS. 1-7, a device according to the invention is indicatedgenerally by the reference numeral 10. The device 10 is intended toocclude a conduit 11. Such occlusion usually will occur on a temporarybasis while a surgical procedure, such as anastomosis, is beingperformed on the conduit 11.

The device 10 includes a first member 12 and a second member 14. Thefirst member 12 has a first end 12 a and a second end 12 b that lie in afirst plane. The second member 14 also has a first end 14 a and a secondend 14 b that lie in the first plane. The first member 12 and secondmember 14 are adapted to extend from one side of the conduit 11 to theother side and to contact, respectively, the conduit 11 on opposingsides thereof.

The occlusion device 10 preferably includes a hinge 16 that connects thesecond ends 12 b, 14 b. Preferably, the hinge 16 is generally U-shapedand constitutes an integral extension of the second ends 12 b, 14 b ofthe first and second members 12, 14. However, the hinge 16 may compriseany technique for connecting the first and second members 12, 14 attheir ends 12 b, 14 b in such a manner that permits the first ends 12,14 a of the occlusion device 10 to be moved in the first plane betweenan open position (shown, for example, in FIGS. 1, 3, and 6) and a closedposition (shown, for example, in FIGS. 2, 4, and 5). In the openposition, the first ends 12 a, 14 a are spaced from each other (seeFIGS. 2 and 4) such that the device 10 can be applied to the conduit 11from the side rather than from the end. The hinge 16 preferablycomprises a spring or is spring-tensioned so as to urge the first andsecond members 12, 14 away from each other.

Desirably, the first ends 12 a, 14 a of the first and second members 12,14 interlock with each other to maintain the first and second members12, 14 in the closed position—or, in other words, in a fixed positionrelative to each other. Preferably, the interlocking is accomplished bymeans of one or more teeth 15 located at end 14 a, the teeth 15interlocking with a blade 13 at end 12 a. However, the occlusion device10 may comprise any other suitable technique to maintain the occlusiondevice 10 in the closed position.

The device 10 may be made from any suitable biocompatible, sterilizablematerial such as stainless steel, tantalum, and, preferably, titanium,and alloys and combinations of any of the foregoing. Since the device 10presumably will not be left in the body after the surgical procedure hasbeen completed, the device 10 also can be made of other materials suchas various plastics and the like.

In use, the first member 12 and second member 14 are placed in a closedposition so as to dispose them generally parallel with each other andsufficiently close to each other to compress the conduit 11 between themand block the passage of fluids therethrough without causing thedevelopment of damaged or necrotic tissue (see FIGS. 4 and 5). Theportions of the first member 12 and second member 14 that contact theconduit 11 are configured to minimize stress concentrations in theconduit 11. In preferred embodiments of the present invention, theportions of the first member 12 and second member 14 that contact theconduit 11 are rounded. In some embodiments, the first and secondmembers 12, 14 are substantially round in cross-section, as illustratedin FIGS. 4, 6, and 7, for example. In other embodiments, thecross-section of the first and second members 12, 14 are eachrectangular with rounded ends, the longer dimension of the rectangleadapted to contact the conduit 11. In embodiments wherein end 14 acomprises multiple teeth, the occlusion device may have multiple closedpositions so as to adapt to various thicknesses of the walls of theconduit 11. This latter feature may also help to minimize stressconcentrations in the conduit 11. It is important to note that theportion of the occlusion device 10 that clamps against the tissue issmooth and has no teeth that press against and traumatize the tissue.

In some embodiments of the present invention, a flexible cover 18 isprovided to cover the substantial length of the first and second members12, 14. The cover 18 does not extend beyond the first ends 12 a, 14 a ofthe first and second members 12, 14 such that the device 10, whenprovided with the flexible cover 18, remains open at the first ends 12a, 14 a of the first and second members 12, 14 when the first and secondmembers 12, 14 are in the first, open position. Also, the interlockconnection between the first ends 12 a, 14 a of the first and secondmembers 12, 14 is not covered. This permits the device 10 to be appliedto the conduit 11 from the side rather than from the end. The cover 18can be made of any material that is biocompatible with the conduit 11and which increases the traction of the members 12, 14 on the conduit11, but the preferred material is a polyester mesh. The cover 18,available preferably as variable density, tends to cushion the contactbetween the conduit 11 and the occlusion device 10 and assists inpreventing undesired bleeding. An opening 20 in the occlusion device 10may be provided for coupling the cover 18 to the occlusion device 10.For example, the cover 18 can be sewn to the occlusion device 10 via theopening 20. In appropriate circumstances, the cover 18 may also befurther sewn to the conduit 11 or nearby portions of the patient's bodyat points 18 a and 18 b, for example.

Referring now to FIGS. 7 and 8, another embodiment of the presentinvention is indicated by the reference numeral 30. The embodiment 30includes certain components identical or similar to those shown in theembodiment 10, and like reference numerals will be used whereappropriate. In the embodiment 30, first and second members 32, 34 arecomparable to first and second members 12, 14. However, the first member32 and the second member 34 include central portions that are generallyarc-shaped when viewed from above and lie in a second plane that isgenerally orthogonal to the first plane. First and second ends 12 a, 12b are defined by straight segments that lie in the first plane and aredisposed in a straight line relative to each other. The arc-shapedcentral portions lie out of the first plane. If desired, the cover 18can be used with the embodiment 30.

As can be seen in FIG. 8, the shape of first and second members 32,34permits first and second members 32, 34 to be disposed toward or awayfrom an operative site while in use. The arc-shaped feature of themembers 32, 34 therefore permits clamping of the conduit 11 to occurcloser to, or further away from, an operative site, while permittinghinging and locking to occur at a location somewhat away from thelocation where the conduit 11 is compressed.

According to one method of the present invention for occluding theconduit 11, a first member 12 is provided, the member 12 being elongateand having first and second ends 12 a and 12 b. The first member 12 hasa cross-section that minimizes stress concentrations in the conduit 11,the first member 12 being long enough to extend from one side of theconduit 11 to the other. The method also includes the step of providinga second member 14, the member 14 being elongate and having first andsecond ends 14 a and 14 b. The second member 14 has a cross-section thatminimizes stress concentrations in the conduit 11, the second member 14being long enough to extend from one side of the conduit 11 to theother.

The method also provides for disposing the first and second members 12,14 on either side of the conduit 11, the members 12, 14 being generallyparallel with each other, and moving the first and second members 12, 14sufficiently close to each other so as to compress the conduit 11between the first and second members 12, 14 without causing thedevelopment of damaged or necrotic tissue. The method also includesmaintaining the first and second members 12, 14 in a compressed positionrelative to the conduit 11.

The present invention also includes the step of providing a cover 18 asa flexible container for containing at least a portion of the first andsecond members 12, 14, the container being long enough to receive boththe first and second members 12, 14 and being made of a material that isbiocompatible with the conduit 11 and which increases traction relativeto the conduit 11. The invention further includes the optional step ofsuturing the flexible container to the conduit 11. The invention alsoincludes the optional step of providing the first and second members 12,14 in an arc-shaped configuration so that clamping of the conduit canoccur closer to, or further away from, an operative site.

As will be apparent from the foregoing description, the occlusion device10 according to the invention is relatively easy to manufacture andsimple to use. The occlusion device 10 provides a convenient way totemporarily occlude the flow of fluids or other material through aconduit while a surgical procedure such as anastomosis is beingperformed. All of this is accomplished in a manner that minimizes stressconcentrations in the conduit 11 and the accompanying formation ofdamaged or necrotic tissue. The device 10 further avoids punctures thatcould lead to difficult-to-control bleeding.

Although the invention has been described in its preferred form with acertain degree of particularity, it will be understood that the presentdisclosure of the preferred embodiments has been made only by way ofexample and that various changes may be resorted to without departingfrom the true spirit and scope of the invention as hereinafter claimed.It is intended that the patent shall cover, by suitable expression inthe appended claims, whatever features of patentable novelty exist inthe invention disclosed.

What is claimed is:
 1. A method for occluding a conduit, comprising thesteps of: providing a first, elongate member having first and secondends, the first member having a cross-section that will minimize stressconcentrations in the conduit, the first member being long enough toextend from one side of the conduit to the other; providing a second,elongate member having first and second ends, the second member having across-section that will minimize stress concentrations in the conduit,the second member being long enough to extend from one side of theconduit to the other; disposing the first and second members on eitherside of the conduit with the longitudinal axes of the first and secondmembers generally parallel with each other; moving the first and secondmembers sufficiently close to each other while maintaining thelongitudinal axes generally parallel with each other to compress theconduit between the first and second members without causing thedevelopment of damaged or necrotic tissue; maintaining the first andsecond members in a compressed position relative to the conduit;providing a flexible container for the first and second members, thecontainer being long enough to receive both the first and secondmembers, the container being made of a material that is biocompatiblewith the conduit and which provides traction relative to the conduit;placing the first and second members in the container prior to the stepof disposing the first and second members on either side of the conduitwith the longitudinal axes of the first and second members generallyparallel with each other; and suturing the flexible container to aselected one of the first member or the second member.
 2. The method ofclaim 1, wherein the step of suturing the flexible container to aselected one of the first member or the second member is accomplished byforming an opening in the first member or the second member and sewingthe container to the opening.
 3. The method of claim 1, wherein theflexible container is a mesh made of polyester fabric.
 4. The method ofclaim 1, wherein those portions of the first and second members thatcome in contact with the conduit are round in cross-section.
 5. Themethod of claim 1, wherein the step of maintaining the first and secondmembers in a compressed position relative to the conduit is accomplishedby providing the first end of a selected one of the first or secondmembers with a protrusion disposed approximately at a right angle to themember from which it extends, the protrusion having a tooth along itslength and the first end of the other member being configured such thatit can engage the tooth and thereby retain the first and second membersin a fixed position relative to each other.
 6. A method for occluding aconduit, comprising the steps of: providing a first, elongate memberhaving first and second ends, the first member having a cross-sectionthat will minimize stress concentrations in the conduit, the firstmember being long enough to extend from one side of the conduit to theother; providing a second, elongate member having first and second ends,the second member having a cross-section that will minimize stressconcentrations in the conduit, the second member being long enough toextend from one side of the conduit to the other; the first and secondends of the first and second members lying in a first plane; providing ahinge that connects the second ends of the first and second members, thehinge being generally U-shaped and constituting an integral extension ofthe second ends of the first and second members to establish a structurethat is closed at the second ends of the first and second members andopen at the first ends of the first and second members when the firstand second members are in a first, open position; providing a flexiblecover for the first and second members, the cover being biocompatiblewith the conduit and providing traction relative to the conduit; whereinthe cover does not extend beyond the first ends of the first and secondmembers such that the device, when provided with the flexible cover,remains open at the first ends of the first and second members when thefirst and second members are in the first, open position; disposing thefirst and second, elongate members on either side of the conduit; movingthe first ends of the first and second members in the first plane fromthe first, open position to a second, closed position in which the firstand second members are disposed generally parallel with each other andbeing disposed sufficiently close to each other to compress the conduitbetween them without causing the development of damaged or necrotictissue; those portions of the first and second members that contact theconduit being configured to minimize stress concentrations in theconduit; and maintaining the first and second members in a compressedposition relative to the conduit.
 7. The method of claim 6, furthercomprising the steps of: forming an opening in a selected one of thefirst or second, elongate members; and sewing the cover to the opening.8. The method of claim 6, wherein the first and second members are madeof a material selected from the group consisting of titanium, titaniumalloys, stainless steel, tantalum, tantalum alloys, and mixturesthereof.
 9. The method of claim 6, wherein the flexible cover is a meshmade of polyester fabric.
 10. The method of claim 6, wherein thoseportions of the first and second members that come in contact with theconduit are round in cross-section.
 11. The method of claim 6, whereinthe step of maintaining the first and second members in a compressedposition relative to the conduit is accomplished by providing the firstend of a selected one of the first or second members with a protrusiondisposed approximately at a right angle to the member from which itextends, the protrusion having a tooth along its length and the firstend of the other member being configured such that it can engage thetooth and thereby retain the first and second members in a fixedposition relative to each other.
 12. The method of claim 11, wherein theprotrusion has a plurality of teeth along its length and the first endof the other member being configured such that it can engage a selectedtooth.
 13. A method for occluding a conduit, comprising the steps of:providing a first member having first and second ends adapted to extendfrom one side of the conduit to the other and to contact the conduit ona selected side thereof; providing a second member having first andsecond ends adapted to extend from one side of the conduit to the otherand to contact the conduit on the other side thereof; the first andsecond ends of the first and second members lying in a first plane;providing a hinge that connects the second ends of the first and secondmembers, the hinge being generally U-shaped and constituting an integralextension of the second ends of the first and second members toestablish a structure that is closed at the second ends of the first andsecond members and open at the first ends of the first and secondmembers when the first and second members are in a first, open position;the first and second members being generally arc-shaped when viewed fromabove and lying in a second plane that is generally orthogonal to thefirst plane; providing a flexible cover for the first and secondmembers, the cover being biocompatible with the conduit and providingtraction relative to the conduit; wherein the cover does not extendbeyond the first ends of the first and second members such that thedevice, when provided with the flexible cover, remains open at the firstends of the first and second members when the first and second membersare in the first, open position; disposing the first and second,elongate members on either side of the conduit; moving the first ends ofthe first and second members in the first plane from the first, openposition to a second, closed position in which the first and secondmembers are disposed generally parallel with each other and beingdisposed sufficiently close to each other to compress the conduitbetween them without causing the development of damaged or necrotictissue; those portions of the first and second members that contact theconduit being configured to minimize stress concentrations in theconduit; and maintaining the first and second members in a compressedposition relative to the conduit.
 14. The method of claim 13, whereinthe first end of a selected one of the first or second members isdefined by a protrusion disposed approximately at a right angle to themember from which it extends, the protrusion having a tooth along itslength and the first end of the other member being configured such thatit can engage the tooth and thereby retain the first and second membersin a fixed position relative to each other.
 15. The method of claim 14,wherein the protrusion has a plurality of teeth along its length and thefirst end of the other member being configured such that it can engage aselected tooth.
 16. The method of claim 13, further comprising the stepsof: forming an opening in a selected one of the first or second,elongate members; and sewing the cover to the opening.
 17. The method ofclaim 13, comprising the step of providing the first and second ends ofthe first and second members with straight segments that lie in thefirst plane.
 18. The method of claim 13, wherein the first and secondmembers are made of a material selected from the group consisting oftitanium, titanium alloys, stainless steel, tantalum, tantalum alloys,and mixtures thereof.
 19. The method of claim 13, wherein the flexiblecover is a mesh made of polyester fabric.
 20. The method of claim 13,wherein those portions of the first and second members that come incontact with the conduit are round in cross-section.